MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC

Model Number 2261

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not be deployed despite several attempts.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of clip would not release from the catheter.Block h10: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was not returned with over sheath.The coil is unraveled next to the bushing.The device did have the clip assembly attached.No activations were found on the clip.The reported event of the clip the wound was clipped, but the clip could not deploy after several attempts, could not be confirmed.Investigation found, the device returned with the clip assembly still attached and it was able to open and close its arms.As part of the analysis, the most distal section was inspected and not discernible failures were observed.The functional inspection was performed using the tortuous fixture as per procedure 91158713, clip deployment test procedure, bsc, ver.M, and it was able to deploy without problems.In addition, the device returned without the over sheath, just with the blue grip attached, but, since there is not enough evidence to clarify the absence of this component, it will be classified as "cause not established".Also, the coil is unraveled next to the bushing, this failure can be caused due to operational factors such as the over sheath removal or insertion/removal from the scope.Therefore, this failure will be classified as "adverse event related to procedure".The investigation findings, and all the information available lead to no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications 51259680, dfu, mb resolution clip, bsc, ver a.No further review is required.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure on june 22, 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not be deployed despite several attempts.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: RESOLUTION CLIP
• Type of Device: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14999183
• MDR Text Key: 297051889
• Report Number: 3005099803-2022-03780
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 2261
• Device Lot Number: 0027804336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 60 KG